vaccine therapy in treating patients with metastatic breast cancer

Conditions: Male Breast Cancer; Recurrent Breast Cancer; Stage IV Breast Cancer

Summary: vaccines may make the body build an immune response to kill tumor cells. this phase i trial is studying the side effects and best dose of vaccine therapy in treating patients with metastatic breast cancer.

primary objectives: i. to assess the toxicity associated with repeated vaccination with an admixture of recombinant vaccinia viruses (rv-muc-1 and rv-tricom). ii. to determine the maximum tolerated dose (mtd) of rv-muc-1 and rv-tricom vaccine admixture. iii. to evaluate the toxicity of adding gm-csf to the admixture of the rv-muc-1 and rv-tricom. secondary objectives: i. to assess host immune reactivity following rv-muc-1 and rv-tricom with and without gm-csf administration. ii. to determine whether vaccination with rv-muc-1 and rv-tricom with and without gm-csf is associated with antitumor activity. outline: this is an open-label, dose-escalation study. patients receive vaccination comprising recombinant vaccinia-muc-1 and recombinant vaccinia-tricom vaccine intradermally on days 1 and 29 (for a total of 2 doses) in the absence of disease progression or unacceptable toxicity. cohorts of 3-6 patients receive escalating doses of recombinant vaccinia-muc-1 and recombinant vaccinia-tricom vaccine until the maximum tolerated dose (mtd) is determined. the mtd is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. once the mtd is determined, an additional 10 patients (including 5 hla-a2-positive patients) receive vaccination as above at the mtd and sargramostim (gm-csf) subcutaneously on days 1-4 and 29-32. patients are followed at 4 weeks, monthly until disease progression, and then annually for up to 15 years. projected accrual: a total of 11-22 patients will be accrued for this study within 18-24 months.

Eligibility criteria:
inclusion criteria: * subjects must have a histologically confirmed diagnosis of metastatic carcinoma of the breast; measurable disease is not required; subjects who are ned are eligible; subjects must have had at least one prior regimen of chemotherapy, immunotherapy, or hormonal therapy prior to entering this study; subjects may have received any number of prior therapies for metastatic disease * subjects must have an ecog performance status of 0-1 * wbc \> 2000/mm\^3 * platelet count \> 100,000/mm\^3 * serum creatinine =\< 2.0 mg/dl * serum bilirubin =\< 1.5 mg/dl * sgpt \< 3 times the upper limit of normal * \>= 4 weeks since chemotherapy (\>= 6 weeks for nitrosoureas or mitomycin c), hormonal therapy or radiation therapy; subjects must have recovered from all acute toxicity associated with the prior regimen; subjects receiving concurrent hormonal treatment or local radiation are not eligible * subjects must be hla typed if not already previously done (5/10 subjects at the mtd dose level must be hla a2 positive) * subjects must not have clinical evidence of altered immune responsiveness or autoimmune syndromes (scleroderma, systemic lupus erythematosus, etc.); subjects must be hiv antibody negative; this treatment may be associated with increased adverse effects for individuals with immune deficiencies, and hiv-associated symptoms preclude accurate assessment of toxicity * subjects must not have undergone splenectomy * the recombinant vaccinia vaccine should not be administered if the following apply to either recipients or, for at least three weeks after vaccination, their close household contacts: persons with active or a history of extensive eczema or other eczematoid skin disorders; those with other acute, chronic or exfoliative skin conditions (e.g., atopic dermatitis, burns, impetigo, varicella zoster, severe acne or other open rashes or wounds) until condition resolves; pregnant or nursing women; children under 5 years of age; and immunodeficient or immunosuppressed persons (by disease or therapy), including hiv infection; close household contacts are those who share housing or have close physical contact; determination of the severity of these conditions will be made by the investigator or co-investigator * subjects must not have any other serious medical condition that in the opinion of the investigator is incompatible with the protocol; subjects with active infections requiring antibiotics are not eligible until the infection has cleared and the antibiotics have been stopped for at least 3 days * subjects must have had prior vaccinia (smallpox) exposure, determined by subject history, medical documentation, or scar characteristic of vaccinia exposure; there must be no history of allergy or untoward reaction to prior vaccinia (smallpox) vaccination * tumor tissue positive for staining with mabs df3 and/or df3-p or elevated serum ca15-3 (also known as ca27-29); note: this can be done on stored slides, but subject will be responsible for costs if not covered by insurance * subjects must not have a history of seizures, encephalitis or multiple sclerosis * subjects must not be allergic to eggs * women of child-bearing potential must agree to use highly effective contraception or abstinence prior to study entry and for at least 4 weeks after the last vaccination; women who are breast-feeding are not eligible for this study; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately * signed informed consent * participants who have been previously treated with vaccinia vectors or muc1 such as those on protocol t98-0057 (dfpcc # 97-050) are not eligible for this study